BACKGROUND
a. Technical Field
[0001] The instant disclosure relates to a filtering circuit for use in an electrophysiology
(EP) system, including an EP system having an ablation generator, an EP recorder,
and/or a mapping and navigation system.
b. Background Art
[0002] US 6,113,595 relates to a device for high-frequency catheter ablation of endomyocardial tissue
and to a corresponding ablation catheter.
[0003] US 2014/358038 A1 relates to a system that automatically detects a tissue pop event so that proper
post-procedures care can be given.
[0004] US 5,300,068 relates to an apparatus for cutting tissue and for ablating occlusions by sensing
the load impedance relative to an output impedance and adjusting the output impedance
to match the load impedance.
[0005] EP 2130507 relates to a filter for simultaneous pacing and ablation.
[0006] Catheters are used for an ever-growing number of procedures. For example, catheters
are used for diagnostic, therapeutic, and ablative procedures, to name just a few
examples. Typically, the catheter is manipulated through the patient's vasculature
and to the intended site such as, for example, a site within the patient's heart.
The catheter typically carries one or more electrodes, which may be used for ablation,
diagnosis, and the like.
[0007] Catheters may be used in a system or laboratory with numerous electrical systems
and components. For example, an ablation system, stimulation system, electrogram system,
and mapping and navigation system may all be used during a single procedure, and may
all transmit, collect, and/or monitor electrical signals of different respective frequencies,
currents, and voltages.
[0008] The foregoing discussion is intended only to illustrate the present field and should
not be taken as a disavowal of claim scope.
BRIEF SUMMARY
[0009] An ablation generator in accordance with the invention is defined in claim 1.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010]
Figure 1 is a diagrammatic view of an exemplary embodiment of an electrophysiology
system.
Figure 2 is an isometric view of an exemplary embodiment of an ablation catheter.
Figure 3 is an isometric view of an exemplary embodiment of a mapping catheter.
Figure 4 is a diagrammatic view of a portion of the electrophysiology system of Figure
1.
Figure 5 is a block diagram view of an exemplary embodiment of a channel of a filtering
circuit that may find use in the electrophysiology system of Figure 1.
Figure 6 is a schematic view of an exemplary embodiment of two channels of a filtering
circuit that may find use in the electrophysiology system of Figure 1, for example.
Figure 7 illustrates position determinations of a mapping and navigation system in
a system without a filtering circuit according to an embodiment of the present disclosure.
Figure 8 illustrates position determinations of a mapping and navigation system in
a system with a filtering circuit according to an embodiment of the present disclosure.
Figures 9A-10B are plots illustrating exemplary pacing functionality of an EP stimulator
and ablation generator.
Figure 11 is a diagrammatic depiction of an exemplary embodiment of a mapping and
navigation system.
DETAILED DESCRIPTION
[0011] Various embodiments are described herein to various apparatuses. Numerous specific
details are set forth to provide a thorough understanding of the overall structure,
function, manufacture, and use of the embodiments as described in the specification
and illustrated in the accompanying drawings. It will be understood by those skilled
in the art, however, that the embodiments may be practiced without such specific details.
In other instances, well-known operations, components, and elements have not been
described in detail so as not to obscure the embodiments described in the specification.
Those of ordinary skill in the art will understand that the embodiments described
and illustrated herein are non-limiting examples, and thus it can be appreciated that
the specific structural and functional details disclosed herein may be representative
and do not necessarily limit the scope of the embodiments, the scope of which is defined
solely by the appended claims.
[0012] Reference throughout the specification to "various embodiments," "some embodiments,"
"one embodiment," or "an embodiment", or the like, means that a particular feature,
structure, or characteristic described in connection with the embodiment is included
in at least one embodiment. Thus, appearances of the phrases "in various embodiments,"
"in some embodiments," "in one embodiment," or "in an embodiment", or the like, in
places throughout the specification are not necessarily all referring to the same
embodiment. Furthermore, the particular features, structures, or characteristics may
be combined in any suitable manner in one or more embodiments. Thus, the particular
features, structures, or characteristics illustrated or described in connection with
one embodiment may be combined, in whole or in part, with the features structures,
or characteristics of one or more other embodiments without limitation given that
such combination is not illogical or non-functional.
[0013] Referring now to the figures, in which like reference numerals indicate the same
or similar elements in the various views, Figure 1 is a diagrammatic view of an exemplary
embodiment of an electrophysiology (EP) system 10. The system 10 may include an EP
stimulator 12, an EP recording system 14, a mapping and navigation system 16, a record
and data consolidation system 18 (shown as "record system" 18 in Figure 1), an ablation
generator 20, a tissue contact and coupling monitor 22 (abbreviated "CM" 22 in Figure
1), and a number of medical devices for performing a diagnostic and/or therapeutic
procedure on a patient 32. For example, in an exemplary embodiment, three elongate
medical devices may be provided: a first mapping and diagnosis catheter 24, a second
mapping and diagnosis catheter 26, and an ablation catheter 28. An RF indifferent
patch 30, for returning an RF ablation signal driven through the ablation catheter
28, may also be provided in the system.
[0014] The instant disclosure provides, among other things, a filtering circuit that may
find use with an EP system combining ablation, electrical impedance-based mapping
and navigation, and/or electrogram recording capabilities (
e.g., the EP system 10 of Figure 1) or another system or laboratory. Such a filtering
circuit may be provided in one or more of the systems and devices illustrated in Figure
1 or in separate hardware. The systems and devices illustrated in Figure 1 will first
be briefly described with reference to Figures 1-3. An exemplary filtering circuit
and the operation of the filtering circuit will then be described with reference to
Figures 4-9. Finally, exemplary pacing functionality that may be performed in conjunction
with an ablation procedure (
e.g., in a system including a filtering circuit according to the present disclosure) will
be described with reference to Figures 10 and 11, and an exemplary mapping and navigation
system will be described with reference to Figure 12.
[0015] Components of the EP System. The electrophysiology stimulator 12 may include one or more devices for providing
and controlling electrical stimulation of an organ of the patient. For example, the
electrophysiology stimulator 12 may include an electronic control unit (ECU) for controlling
the provision of electrical stimulation pulses (also referred to herein as pacing
signals) intended for a patient's heart and a circuit for producing such pulses. Such
pulses may be provided, for example, during an electrophysiology study of the heart
through, for example, one or more of the mapping catheters 22, 24 or the ablation
catheter 26. In an exemplary embodiment, the EP stimulator may comprise an EP-4™ Cardiac
Stimulator commercially available from St. Jude Medical, Inc. of St. Paul, Minnesota.
[0016] The EP recording system 14 may include one or more devices configured to obtain,
record, and/or display an electrogram respective of the patient 32. For example, the
EP recording system 14 may include or be electrically coupled with a set of electrocardiogram
(ECG) patches and may record and display an electrocardiogram or other electrogram
for clinician review. The EP recording system 14 may additionally or alternatively
collect, record, and/or display ECG or other electrogram data measured with or by
the ablation generator 20, the mapping and navigation system 16, and/or another component
of the EP system 10. In an embodiment, the EP recording system may comprise the WorkMate™
Claris™ Recording System commercially available from St. Jude Medical, Inc. of St.
Paul, Minnesota.
[0017] The mapping and navigation system 16 may be provided for various functions including,
but not limited to, determining the location (
i.e., position and orientation) of an elongate medical device (such as one or more of the
mapping catheters 22, 24 and the ablation catheter 26) within the body of the patient
32, mapping the anatomy of the patient 32, etc. The mapping and navigation system
16 may comprise an electrical impedance-based system, such as, for example, an EnSite™
Velocity™ cardiac electro-anatomic mapping system running a version of EnSite™ NavX™
navigation and visualization technology software commercially available from St. Jude
Medical, Inc., of St. Paul, Minnesota and as also seen generally by reference to
U.S. Patent Nos. 7,263,397 and
7,885,707, both hereby incorporated by reference in their entireties. In other exemplary embodiments,
the mapping and navigation system 16 may comprise systems other than electric impedance-based
systems. For example, the mapping and navigation system 16 may comprise a magnetic
field-based system such as the Carto™ system commercially available from Biosense
Webster, and as generally shown with reference to one or more of
U.S. Patent Nos. 6,498,944;
6,788,967; and
6,690,963. In another exemplary embodiment, the mapping and navigation system 16 may comprise
a magnetic field-based system based on the MediGuide™ technology available from St.
Jude Medical, Inc., and as generally shown with reference to one or more of
U.S. Patent Nos. 6,233,476;
7,197,354; and
7,386,339. In yet another embodiment, the mapping and navigation system 16 may comprise a combination
electrical impedance-based and magnetic field-based system, such as, for example and
without limitation, the system described in pending
U.S. Patent Application No. 13/231,284, or the Carto™ 3 system commercially available from Biosense Webster, and as generally
shown with reference to
U.S. Patent No. 7,536,218. In yet still other exemplary embodiments, the mapping and navigation system may
comprise or be used in conjunction with other commonly available systems, such as,
for example and without limitation, fluoroscopic, computed tomography (CT), and magnetic
resonance imaging (MRI)-based systems.
[0018] An exemplary embodiment of an electrical impedance-based mapping and navigation system
is illustrated in Figure 12 and described in detail with reference to Figure 12 at
the end of this Detailed Description. Briefly, an electrical impedance-based mapping
and navigation system may operate by driving electrical currents along several axes
through the patient's body. For example, currents may be driven between pairs of cutaneous
patch electrodes. The signals may have a frequency on the order of kilohertz (kHz),
in an embodiment. For example, the signals may have a frequency between about six
(6) kHz and about ten (10) kHz. Still further, for example, the signals may have a
frequency of about eight (8) kHz, such as 8.138 kHz, in an embodiment. Electrodes
within the patient's body may be used to detect the electrical signals, and the location
of an electrode may be determined by assessing the detected signals.
[0019] The mapping and navigation system 16 may be further configured to collect EP and/or
positioning data from the mapping catheters 24, 26. Based on such data, the mapping
and navigation system 16 may be configured to, among other things, construct a model
of patient tissue (
e.g., of the heart), construct an EP map of patient tissue, etc.
[0020] With continued reference to Figure 1, the record and data consolidation system 18
may include one or more devices configured to provide communication between the mapping
and navigation system 16 and the EP recording system 14 to link data collection before,
during and after a procedure. The record and data consolidation system 18 may be further
configured to store, retrieve, display, and/or transmit patient data and other information,
in an embodiment.
[0021] The record and data consolidation system 18 may provide a single system through which
a clinician (
e.g., a physician) may access data from either the EP recording system 14, the mapping
and navigation system 16, and/or other systems that would otherwise be separate. For
example, the record and data consolidation system 18 may be configured to provide
the clinician with a single patient record including EP recording and charting (
e.g., from the EP recording system 14) and maps and images of the patient's anatomy (
e.g., from the mapping and navigation system 16). The record and data consolidation system
18 may comprise, in an embodiment, an EnSite™ Derexi™ module commercially available
from St. Jude Medical, Inc. of St. Paul, Minnesota.
[0022] The tissue contact and coupling monitor 22 may be configured to perform one or more
measurements, calculations, and output functions related to determining a contact
or coupling state between a medical device and patient tissue, in an embodiment. The
tissue contact and coupling monitor 22 may receive measurements respective of electrical
characteristics of patient tissue from one or more electrodes included on the mapping
catheters 22, 24, for example, and determine a coupling or contact state between one
of the mapping catheters 22, 24 (
e.g., an electrode disposed on one of the mapping catheters 22, 24) and the tissue based
on the measurements. Such measurements and/or calculations may include, for example
only, a complex impedance (
i.e., reactance and resistance or impedance magnitude and phase angle), electrical coupling
index (ECI), and/or other metric. Exemplary metrics and the use of such metrics for
determining a contact or coupling state are described in greater detail in, for example,
U.S. patent application publication no. 2009/0275827, which is hereby incorporated by reference in its entirety. Complex impedance, ECI,
and similar metrics may also be used to assess the formation of lesions during or
after an ablation procedure as described, for example, in
U.S. patent application publication no. 2011/0118727.
[0023] The ablation generator 20 may be configured to provide an RF ablation signal for
performing an ablation procedure (
e.g., on a portion of the heart of the patient 32). Accordingly, the ablation generator
20 may be configured to drive an RF ablation signal through one or more electrodes
on the ablation catheter 28, which signal may be returned through the RF indifferent
patch 30. The ablation generator 20 may comprise or may include the functionality
of, for example, the Ampere™ RF Ablation Generator or the IBI-1500T9-CP Cardiac Ablation
Generator, both commercially available from St. Jude Medical, Inc. of St. Paul, Minnesota.
[0024] The ablation generator 20 may be further configured to collect signals respective
of electrical activity of an organ of the patient 32 (
i.e., electrogram signals), in an embodiment. For example, the ablation generator 20 may
be configured to receive electrical signals collected with one or more electrodes
on the ablation catheter 28. The ablation generator 20 may be further configured to
provide such signals to one or more other components or systems within the EP system
10 such as, for example, to the tissue contact and coupling monitor 22. The EP system
10 may include a signal path between the ablation generator 20 and one or more other
systems or devices in the EP system 10. For example, the EP system may include a signal
path between the ablation generator 20 and the EP recording system 14, in an embodiment,
for the EP recording system 14 to receive electrogram signals or data collected by,
with, or through the ablation generator 20. This signal path may be referred to herein
as the "electrogram signal path." The electrogram signal path may be direct or indirect,
in embodiments. For example, as illustrated in Figure 1, the electrogram signal path
may go through the tissue contact and coupling monitor 22 and the record and data
consolidation system 18. A signal path from the EP stimulator 12 to the ablation generator
20 may also be provided and may coincide, in part, with the electrogram signal path,
in an embodiment.
[0025] The ablation generator 20 may be further configured to receive a pacing signal from,
for example, the tissue contact and coupling monitor 22. The pacing signal may be
originally generated, in an embodiment, by the EP stimulator 12, in an embodiment.
The ablation generator 20 may be configured to provide the pacing signal through the
ablation catheter 28. The pacing signal may be applied to tissue through, for example
only, one or more electrodes of the ablation catheter 28.
[0026] One or more of the EP stimulator 12, the EP recording system 14, the mapping and
navigation system 16, the record and data consolidation system 18, the ablation generator
20, and the tissue contact and coupling monitor 22 may include processing apparatus
for performing the functions described herein. For example, one or more of the EP
stimulator 12, the EP recording system 14, the mapping and navigation system 16, the
record and data consolidation system 18, the ablation generator 20, and the tissue
contact and coupling monitor 22 may include a respective ECU comprising a respective
processor and a respective memory. The memory may store instructions that, when executed
by the processor, cause the ECU to perform one or more of the functions described
herein. Additional or alternative processing apparatus means may be provided, such
as an application-specific integrated circuit (ASIC), field-programmable gate array
(FPGA), or programmable logic device (PLD), for example only.
[0027] One or more the EP stimulator 12, the EP recording system 14, the mapping and navigation
system 16, the record and data consolidation system 18, the ablation generator 20,
and the tissue contact and coupling monitor 22 may further include a respective display
and/or other input and output devices.
[0028] In an embodiment, one or more of the systems and devices illustrated separately in
Figure 1 may be included in a consolidated system or apparatus. For example, in an
embodiment, the EP stimulator 12, EP recording system 14, and the record and data
consolidation system 18 may be provided in a single system, product, or unit. For
example, the EP stimulator 12, EP recording system 14, and the record and data consolidation
system 18 may collectively comprise a WorkMate™ Claris™ Recording System commercially
available from St. Jude Medical, Inc. of St. Paul, Minnesota.
[0029] Exemplary embodiments of the ablation catheter 28 and the first mapping catheter
22 are illustrated in Figures 2 and 3, respectively. Referring to Figure 2, which
is an isometric view of the ablation catheter 28, the ablation catheter 28 may comprise
a shaft 34 having a distal end portion 36 and a proximal end portion 38. The ablation
catheter 28 may be configured to be guided through and disposed in the body of a patient.
Accordingly, the proximal end portion 38 may be coupled to a handle 40, which may
include features to enable a physician to guide the distal end portion 36 to perform
a diagnostic or therapeutic procedure such as, for example only, an ablation procedure
on the heart of the patient. Accordingly, the handle 40 may include one or more manual
manipulation mechanisms such as, for example, rotational mechanisms and/or longitudinal
mechanisms, coupled to pull wires for deflecting the distal end portion 36 of the
shaft 34. Exemplary embodiments of manipulation mechanisms, pull wires, and related
hardware are described, for example only, in
U.S. patent application publication no. 2012/0203169. The handle 40 may further include one or more electromechanical connectors for coupling
to a mapping and navigation system, an ablation generator, and/or other external systems.
The handle 40 may also include one or more fluid connectors for coupling to a source
and/or destination of fluids such as, for example only, a gravity feed or fixed or
variable-rate pump.
[0030] The distal end portion 36 of the shaft 34 may include a number of ring electrodes
42 and a tip electrode 44 for applying ablation energy to tissue, acquiring electrophysiology
data from tissue, sensing positioning signals used to determine the position and orientation
(P&O) of the shaft, and/or other purposes. The electrodes 42, 44 may be coupled to
electrical wiring within the shaft 36, which wiring may extend to the handle 40 and
to electromechanical connectors for coupling to external systems.
[0031] The distal end portion 36 of the shaft 34 may also include one or more fluid ports
or manifolds for distributing or collecting fluids such as, for example only, irrigation
fluid during an ablation procedure. The fluid ports may be fluidly coupled with one
or more fluid lumens extending through the shaft 36 to the handle 40 and a fluid connector
for coupling to external fluid sources and/or destinations.
[0032] Figure 3 is an isometric view of an exemplary embodiment of the first mapping catheter
24, wherein the first mapping catheter 24 has a distal lariat portion (
i.e., the illustrated embodiment of the first mapping catheter 24 is a spiral mapping catheter).
The first mapping catheter 24 may comprise a shaft 46 having a distal end portion
48 and a proximal end portion 50. The first mapping catheter 24 may be configured
to be guided through and disposed in the body of a patient. Accordingly, the proximal
end portion 50 of the shaft 46 may be coupled to a handle 52, which may include features
to enable a physician to guide the distal end portion to perform a diagnostic or therapeutic
procedure such as, for example only, a mapping procedure on the heart of the patient.
Accordingly, the handle 52 may include one or more manual manipulation mechanisms
54 such as, for example, rotational mechanisms and/or longitudinal mechanisms, coupled
to pull wires for deflecting the distal end portion of the shaft. Exemplary embodiments
of manipulation mechanisms, pull wires, and related hardware are described, for example
only, in
U.S. patent application publication no. 2012/0203169, referenced above. The handle 52 may further include one or more electromechanical
connectors for coupling to a mapping and navigation system, an ablation generator,
and/or other external systems. The handle 52 may also include one or more fluid connectors
for coupling to a source and/or destination of fluids such as, for example only, a
gravity feed or fixed or variable-rate pump.
[0033] The distal end portion 48 of the shaft may have a portion having a lariat shape.
In an embodiment, the lariat shape may be formed by, for example, a shape memory wire
disposed within the shaft. A tip electrode and a number of ring electrodes (similar
to the tip and ring electrodes 44, 42 on the ablation catheter 28 and shown in Figure
2) may be disposed on the distal end portion 48 of the shaft 46, in an embodiment.
For example, a tip electrode and a plurality of ring electrodes may be disposed on
the lariat portion of the shaft 46. In an embodiment, the distal end portion 48 may
include nine (9) ring electrodes (
i.e., a "decapolar" catheter having ten total electrodes) or nineteen (19) ring electrodes
(
i.e., a "duo-decapolar" catheter having twenty total electrodes). The electrodes may be
coupled to electrical wiring within the shaft 46, which may extend to the handle 52
and to electromechanical connectors for coupling to external systems.
[0034] The catheter embodiments 24, 28 illustrated in Figures 2 and 3 are exemplary in nature
only. Numerous types of catheters may find use in the EP system 10 of Figure 1, as
may numerous types of elongate medical devices, including catheters, introducers,
guidewires, and the like. For example, the second mapping catheter 26 may be a coronary
sinus catheter, in an embodiment, or other mapping catheter. Thus, embodiments including
one or more elongate medical devices other than the catheters explicitly illustrated
and described herein remain within the spirit and scope of the present disclosure.
[0035] Referring again to Figure 1, the mapping catheters 24, 26 may be configured (
e.g., through electrodes disposed on the respective shafts of the mapping catheters 24,
26) to collect electrical signals from the patient's body and to provide the electrical
signals to the tissue contact and coupling monitor 22 for monitoring of contact and
coupling between the electrodes and patient tissue. The electrical signals collected
by the mapping catheters 24, 26 may also be provided to the mapping and navigation
system 16 for,
e.g., building a model and/or an EP map of the heart of the patient 32 or of a portion
of the heart of the patient 32.
[0036] As noted above and in the various above-referenced patents and patent applications,
a number of electrical signals may be transmitted and/or measured in and through the
body of the patient 32 during a diagnostic and/or therapeutic procedure using the
EP system 10 or components of the EP system 10. For example, during an ablation and
monitoring procedure, various electrical signals may be transmitted by the components
of the EP system 10, including positioning signals by the mapping and navigation system
16, ablation signals, and pacing signals. Furthermore, signals produced by the tissue
of the patient 32, such as an ECG and/or localized electrical activity, may be monitored
to,
e.g., monitor tissue functionality to determine if a desired ablation lesion has been formed,
to display for a clinician, etc. Accordingly, to maintain signal fidelity in the intended
systems (
i.e., positioning signal fidelity for the mapping and navigation system 16, electrogram
signal fidelity for the EP recording system 14, etc.), one or more filtering circuits
may be provided in the EP system 10 to minimize diversion or leakage of electrical
currents from their intended paths.
[0037] In addition to unintended signal diversion or leakage, an issue in the electrical
circuitry of the EP system 10 and other systems and laboratories may be properly protecting
the various systems and devices from the signals emitted by the other devices and
systems and/or filtering to be able to properly observe signals of a desired frequency.
For example, electrogram signals (which may have a relatively low frequency and/or
voltage) may be collected with the same electrodes that are used to drive ablation
currents (which may be of a higher frequency and/or voltage). Furthermore, the current
and/or voltage of the ablation signal may be higher than signals that the EP recording
system 14 and/or other systems and devices are normally configured to receive. Accordingly,
filtering the ablation signal from being returned through the electrogram signal path
may be beneficial both for signal fidelity and for protecting equipment in the EP
system.
[0038] The benefits of a filtering circuit listed above are exemplary in nature only. A
filtering circuit according to the present disclosure may provide numerous benefits
in addition to or instead of those expressly set forth herein, in embodiments.
[0039] Filtering Circuit. Figure 4 is a diagrammatic view of a portion of the EP system illustrated in Figure
1. More specifically, Figure 4 illustrates the ablation generator 20, an input/output
(I/O) cable 56 for the ablation catheter, and an electrogram I/O cable 58.
[0040] The ablation catheter I/O cable 56 may be mechanically and electrically coupled to
a first port 60 provided on the ablation generator 20. Ablation signals and/or other
signals and data may be output to the ablation catheter through the ablation catheter
I/O cable 56, and electrogram signals and/or other signals and data may be input to
the ablation generator 20 through the ablation catheter I/O cable 56. Accordingly,
the first port 60 may comprise or may be electrically coupled with an input node for
electrogram signals.
[0041] The electrogram I/O cable 58 may be mechanically and electrically coupled to a second
port 62 provided on the ablation generator. Electrogram signals and/or other signals
or data may be output by the ablation generator 20 through the electrogram I/O cable
58, and pacing signals and/or other signals or data may be input to the ablation generator
20 through the electrogram I/O cable 58. Accordingly, the second port 62 may comprise
or may be electrically coupled with an output node for electrogram signals and/or
an input node for pacing signals.
[0042] As noted above, one or more electrodes on an ablation catheter may be used to collect
electrogram signals, which signals may be provided to the ablation generator 20 from
the ablation catheter through the ablation catheter I/O cable 56, and from the ablation
generator 20 to one or more other systems or devices (such as the tissue contact and
coupling monitor 22 or the EP recording system 14, for example -
see Figure 1). Accordingly, the ablation generator 20 may include a signal path 64 from
the ablation catheter I/O cable 56 to the electrogram I/O cable 58. This signal path
may be a portion of the electrogram signal path referenced above and below.
[0043] The ablation generator 20 may include, in an embodiment, an ablation signal generation
circuit 66, a filtering circuit 68, and the above-mentioned first and second I/O ports
60, 62. The ablation signal generation circuit 66 may be configured to generate and
output an RF signal having signal characteristics appropriate for performing an ablation
procedure on tissue of a patient such as, for example, the heart. The ablation signal
generation circuit 66 may be electrically coupled with the first I/O port 60 for outputting
the ablation signal through the ablation catheter I/O cable 56 to the ablation catheter.
In an embodiment, the ablation signal may have a frequency of between four hundred
and fifty (450) kilohertz (kHz) and five hundred (500) kHz, for example. Still further,
the ablation signal may have a frequency of about four hundred and eighty-five (485)
kHz, for example. Of course, other ablation signal frequencies may be generated in
addition to or instead of a 450-500kHz signal.
[0044] The filtering circuit 68 may be disposed between the first port 60 (
i.e., the electrogram input node) and the second port 62 (
i.e., the electrogram output node), in an embodiment. More broadly, the filtering circuit
68 may be electrically disposed in the electrogram signal path. Accordingly, the illustrated
embodiment, in which the filtering circuit 68 is included in the ablation generator
20, is exemplary in nature only. Referring to Figures 1 and 4, the filtering circuit
68, or portions thereof, may additionally or alternatively be provided in the a tissue
contact and coupling monitor 22, in the record and data consolidation system 18, in
the EP recording system 14, or in another system or apparatus or in independent hardware,
in embodiments.
[0045] The filtering circuit 68 includes two filter channels. The filtering circuit 68 may
include the same number of channels as the number of electrodes on the ablation catheter,
in an embodiment. For example, referring to Figures 2 and 4, in an embodiment in which
the filtering circuit is configured to function with the illustrated embodiment of
the ablation catheter 28, the filtering circuit may include four (4) channels (not
according to the invention). One dedicated channel may be provided in the filtering
circuit 68 for each electrode on the ablation catheter. The channels are parallel.
[0046] Figure 5 is a diagrammatic view of an exemplary embodiment of a channel 70 of the
filtering circuit, illustrating the signal path from an electrode 42, 44 (
e.g., on the ablation catheter) to an electrogram output 72 (
e.g., the second port 62 of the ablation generator,
see Figure 4). The filtering circuit channel 70 may a gas tube discharge portion 74,
a mapping and navigation signal filter portion 76, and an ablation signal filter portion
78. The channel 70 may be provided between an electrogram input node and an electrogram
output node.
[0047] The mapping and navigation signal filter portion 76 is provided to present a high
impedance (
e.g., ten (10) kilo-ohms (kΩ) or more) to signals having a frequency of or near the frequencies
used by the mapping and navigation system 16 (
see Figures 1 and 12) such as, for example, the signals driven through the patient's
body for position determination purposes. Because the impedance in the signal path
including the mapping and navigation signal filter portion 76 (
i.e., through the filter channel 70) may be significantly higher than the impedance through
the patient's body and the impedance presented by the signal path provided between
electrodes 42, 44 and the mapping and navigation system, the position determination
signals will not be diverted (or will be minimally diverted) through the electrogram
signal path.
[0048] The ablation signal filter portion 78 may be provided to present a high impedance
(
e.g., ten (10) kΩ or more) to signals having a frequency of or near the frequencies used
by the ablation generator 20 (
see Figures 1 and 4) such as, for example, the signal driven through the ablation catheter
and RF indifferent patch for ablating tissue. Because the impedance in the signal
path including the ablation signal filter portion may be significantly higher than
the impedance through the patient's body, ablation signals will not be diverted (or
will be minimally diverted) through the electrogram signal path from its intended
signal path. As a result, other components and equipment may be protected from high
ablation currents, and the patient may be protected from ablation currents flowing
between electrodes on the ablation catheter (
i.e., using a first electrode on the ablation catheter as a source and a second electrode
on the catheter as a sink), rather than between a single electrode and an RF indifferent
patch.
[0049] Figure 6 is a schematic view of an exemplary two-channel embodiment 80 of the filtering
circuit. The two channels 82
1, 82
2 may be identical, in an embodiment, as illustrated in Figure 6. Accordingly, a single
channel 82 is described below, but it should be understood that such description may
apply to a respective channel 82 for each electrode on an ablation catheter, in an
embodiment. Identical or similar components in the channels 82 are designated with
a subscript "1" in the first channel and a subscript "2" in the second channel in
Figure 6, but are described generically without subscripts.
[0050] A channel 82 includes a mapping and navigation signal filter portion 76 and an ablation
signal filter portion 78 (the gas discharge tubes shown in Figure 5 are omitted in
Figure 6). The mapping and navigation filter signal portion 76 and ablation signal
filter portion 78 each comprise a respective one or more LC traps 84. Accordingly,
the channel includes a plurality of LC traps 84 (for clarity of illustration, not
all LC traps 84 are designated in Figure 6). Each LC trap 84 includes an inductor
86 in parallel with a capacitor 88 (for clarity of illustration, not all inductors
86 and capacitors 88 are designated in Figure 6). The LC traps 84 are electrically
connected to each other in series. The mapping and navigation signal filter portion
76 may include three (3) or more LC traps 84, in an embodiment. Eight (8) LC traps
84 are included in the embodiment of the mapping and navigation signal filter portion
76 illustrated in Figure 6. The ablation signal filter portion 78 may include two
or more LC traps 84, in an embodiment. A channel 82 and/or a node between two or more
channels 82
1, 82
2, may additionally include other capacitors, inductors, resistors, and other electrical
components for inputting, outputting, amplifying, and conditioning signals, and the
like.
[0051] The peak frequency
f (in hertz) of an LC trap is defined by equation 1, below:

where L is the inductance value of the inductor (in Henry) and C is the capacitance
value of the capacitor (in farads). Two or more of the LC traps 84 are tuned to the
same frequency.
[0052] The LC traps 84 in the mapping and navigation signal filter portion 76 are be tuned
to respective peak frequencies at or near one or more frequencies used by a mapping
and navigation system 16 (
see Figure 1. A first plurality of the LC traps of the first filter portion is tuned
to a first same peak frequency between 6 kHz and 8 kHz. A second plurality of the
LC traps of the first filter portion is tuned to a second same peak frequency between
6 kHz and 7 kHz.
[0053] In an embodiment, one or more of the LC traps 84 in the ablation signal filter portion
78 may be tuned to respective peak frequencies at or near one or more frequencies
used by an ablation generator 20 (
see Figures 1 and 4) or the harmonics of such frequencies, such as second order and higher
harmonics, or of the same order of magnitude of such frequencies and harmonics. For
example, in an embodiment in which the ablation generator produces ablation signals
having a frequency of 485 kHz, for example, one or more of the LC traps 84 in the
ablation signal filter portion 78 may be tuned to respective peak frequencies at or
around 485 kHz and/or a harmonic of 485 kHz. For example, one of the LC traps 84 in
the ablation signal filter portion 78 may be tuned to a peak frequency of 485 kHz,
and another LC trap 84 in the ablation signal filter portion 78 may be tuned to a
harmonic of 485 kHz, such as the third harmonic of 485 kHz (at 1.455 MHz), for example
only.
[0054] By presenting a high impedance to signals having frequencies at or near the peak
frequencies of the LC traps 84, a filtering circuit according to the present disclosure
may discourage the flow of such signals through the filtering circuit. Accordingly,
by placing the filtering circuit in the electrogram signal path and tuning the peak
frequencies of the LC traps 84 to frequencies at or near the frequencies of position
determination signals, ablation signals, and other signals, such position determination
signals, ablation signals, and other signals may be effectively prevented from being
diverted through the electrogram signal path.
[0055] In an embodiment, additional filtering of the ablation signal in each channel may
be provided by a resistor-capacitor (RC) filter comprising a resistor 87 and a capacitor
89. The resistor may have a relatively low impedance value, on the order of 25 ohms,
in an embodiment, so as not to interfere with pacing. The capacitor 89 may be large
enough that the RC filter is centered at a frequency below the fundamental ablation
frequency, but not so large as to shunt the electrogram signal or the navigation signal.
For example, a value on the order of 33 nanofarads may be appropriate, in an embodiment.
A node 85 that couples the capacitors 89
1, 89
2, together may additionally couple similarly-placed capacitors in embodiments with
additional channels. Output from the channels may be provided at output nodes 91
1, 91
2.
[0056] Although the filtering circuit is described above with respect to an embodiment having
two substantially identical channels, it should be understood that different channels
may differ, in an embodiment, so as to provide different types of filtering (
e.g., different impedances and/or different frequencies) in different channels. For example,
in an embodiment, the filtering circuit may be configured to function with a four-electrode
catheter having a tip electrode and three ring electrodes (
see Figure 2). In practice, a physician may typically use such a catheter to view bipolar
electrograms collected with adjacent electrode pairs, such as the tip electrode with
the first ring electrode and the second ring electrode with the third ring electrode.
Accordingly, in such an embodiment, the filtering circuit may be configured to filter
substantially equally between the tip electrode and the first ring electrode and between
the second and third ring electrodes, but to minimally filter between the first ring
electrode and the second ring electrode, which may not commonly be used in a bipolar
pair. Respective configurations of embodiments of the filtering circuit may be similarly
tailored to common uses of medical devices with which those filtering circuit embodiments
are used.
[0057] Although the filtering circuit is described herein with specific reference to filtering
position determination signals from a mapping and navigation system and ablation signals,
a filtering circuit according to the present disclosure may include filter portions
for additional or alternative signals. That is, a filtering circuit is not limited
to filtering a particular frequency or set of frequencies except as expressly set
forth in the claims.
[0058] Figures 7-9 are diagrammatic views of a display 90 and user interface 92 that may
find use in an EP system, illustrating electrode position and catheter shape determinations
with and without a filtering circuit. Figure 7 illustrates a catheter representation
based on position determinations of a mapping and navigation system in a broader system
lacking a circuit for filtering position determination frequencies from an electrogram
(
i.e., such that position determination signals are diverted through an electrogram signal
path). Figure 8 illustrates catheter representations based on position determinations
of a mapping and navigation system in a broader system having a circuit for filtering
position determination frequencies from an electrogram.
[0059] Figure 7 illustrates a display 90 and user interface 92 that may be a part of, for
example only, a mapping and navigation system. As described herein, the mapping and
navigation system may determine the positions of one or more electrodes within the
patient's body according to electrical signals detected with the electrodes that are
transmitted by cutaneous patch electrodes, in an embodiment. Figure 7 includes illustrations
of a distal end portion 94 of an elongate medical device with the distal end portion
deflected. A first illustration 96a of the elongate medical device 94 represents the
"true" shape of the distal end portion. A second illustration 96b of the elongate
medical device represents the shape of the distal end portion as determined by a mapping
and navigation system used in an EP system without a filtering circuit according to
the present disclosure. Accordingly, position determination signals of the mapping
and navigation system are diverted through the electrogram signal path, and position
determinations are skewed such that the determined positions of the tip electrode
and first ring electrode result in a distorted reconstruction of the shape of the
distal end portion of the elongate medical device in the second illustration 96b.
[0060] Figure 8 illustrates the display 90 and user interface 92, including representations
of the distal end portion of the elongate medical device 94 with the distal end portion
deflected. A first illustration 96a of the elongate medical device represents the
"true" shape of the distal end portion, and second and third illustrations 96b, 96c
of the elongate medical device represents the shape of the distal end portion as determined
by a mapping and navigation system used in an EP system with a filtering circuit according
to the present disclosure. As can be seen comparing Figure 8 with Figure 7, by using
a filtering circuit according to the present disclosure, position determinations made
by a mapping and navigation system may be more accurate.
[0061] Pacing Functionality. While preventing leakage of position determination signals from a mapping and navigation
system and return of ablation signals, a filtering circuit according to the present
disclosure may provide relatively low impedance for pacing signals (
e.g., provided by an EP stimulator 12,
see Figure 1), in an embodiment, permitting pacing signals to be driven through an ablation
catheter in addition to or instead of an ablation signal. Figures 9 and 10 are plots
illustrating a ten (10) millisecond (ms) pacing pulse being driven through an ablation
catheter, measured between a tip electrode and first ring electrode (
e.g., tip electrode 44 and adjacent ring electrode 42,
see Figure 2). Figure 9 illustrates an exemplary pacing pulse as generated by an EP stimulator,
with a first representation 98 in Figure 9 illustrating the voltage of the pulse (where
a voltage of the pulse may be about two volts, in an exemplary embodiment), and a
second representation 100 in Figure 9 representing the current of the pulse (where
a current of the pulse may be about four milliamps, in an exemplary embodiment). Figure
10 illustrates the same exemplary pacing pulse in the presence of a small ablation
voltage used for monitoring, with a first representation 102 in Figure 10 illustrating
the voltage between the tip electrode and the first ring electrode, and a second representation
104 in Figure 10 representing the current of the tip electrode to the first ring electrode.
As illustrated, the pacing signal produced by the EP stimulation system is substantially
transmitted by the ablation catheter electrode and "rides" on the ablation signal.
[0062] Exemplary Mapping and Navigation System. Figure 11 is a diagrammatic depiction of an embodiment of an exemplary mapping and
navigation system 16 that may incorporate various functionality including, but not
limited to, determining the location (
i.e., position and orientation) of an elongate medical device 110 within the body of a
patient 32, mapping the anatomy of the patient 32, etc.
[0063] The system 16 may include an electronic control unit (ECU) 112, an analog-to-digital
converter (A-to-D) 114, a lowpass filter (L.P.) 116, a switch 118, a signal generator
120, and a plurality of body surface (
i.e., cutaneous) patch electrodes 122. The system 16 may be electronically and/or mechanically
coupled with an elongate medical device 110. The system may be configured for a number
of functions for guiding the elongate medical device 110 to a target site within the
body of a patient 32, such as the heart 124, and for assessing contact between the
elongate medical device 110 and the tissue of the patient 32. The system 16 may further
include a conventional set of ECG leads 126 for the capture and measurement of patient
ECG data.
[0064] The elongate medical device 110 may be one of the catheters 24, 26, 28 described
herein (
see Figures 1-3), or some other elongate medical device. The elongate medical device
110 may have one or more electrodes 128. The one or more electrodes may include a
tip electrode 44 (
see Figure 2), one or more ring electrodes 42 (
see Figure 2), and/or another type of electrode.
[0065] The ECU 112 may include a memory 130 and a processor 132. The memory 130 may be configured
to store data respective of the elongate medical device 110, of the patient 32, and/or
other data. Such data may be known before a medical procedure, or may be determined
and stored during a procedure. The memory 130 may also be configured to store instructions
that, when executed by the processor 132, cause the ECU 112 to perform one or more
methods, steps, functions, or algorithms described herein.
[0066] The system may be configured to determine the position and orientation (P&O) of the
elongate medical device 110 (
e.g., of a distal end portion of the elongate medical device 110) within the body of the
patient 32. Accordingly, the ECU 112 may be configured to control generation of one
or more electrical fields and determine the position of one or more electrodes 128
within those fields. The ECU 112 may thus be configured to control the signal generator
120 in accordance with predetermined strategies to selectively energize various pairs
(dipoles) of body surface patch electrodes 122 and catheter electrodes 128.
[0067] The body surface patch electrodes 122 may be used to generate axes-specific electric
fields within the body of the patient, and more specifically within the heart 124,
in an embodiment. Three sets of patch electrodes may be provided: (1) electrodes 122
X1, 122
X2 (X-axis); (2) electrodes 122
Y1, 122
Y2 (Y-axis); and (3) electrodes 122
Z1, 122
Z2 (Z-axis). Additionally, a body surface electrode ("belly patch") 122
B may be provided as an electrical reference. The body patch electrodes 122
X1, 122
X2, 122
Y1, 122
Y2, 122
Z1, 122
Z2, 122
B may be referred to herein generically as a body patch electrode 122 or as the body
patch electrodes 122. Body patch electrode configurations and combinations other than
those explicitly illustrated and described are suitable for use with the present disclosure,
including fewer body patch electrodes 122, more body patch electrodes 122, or different
physical arrangements,
e.g. a linear arrangement instead of an orthogonal arrangement.
[0068] Each patch electrode 122 may be independently coupled to the switch 118, and pairs
of patch electrodes may be selected by software running on the ECU 112 to couple the
patch electrodes 122 to the signal generator 120. A pair of electrodes 122, for example
the Z-axis electrodes 122
Z1, 122
Z2, may be excited by the signal generator 120 to generate an electrical field in the
body of the patient 32 and, more particularly, within the heart 124, by driving a
current between the excited electrodes. Such driven currents are referred to above
as positioning determination signals.
[0069] In an embodiment, this electrode excitation process occurs rapidly and sequentially
as different sets of patch electrodes 122 are selected and one or more of the unexcited
surface electrodes 122 are used to measure voltages. During the delivery of the excitation
signal (
e.g., current pulse), the remaining (unexcited) patch electrodes 122 may be referenced
to the belly patch 122
B and the voltages impressed on these remaining electrodes 122 may be measured. In
this fashion, the patch electrodes 122 may be divided into driven and non-driven electrode
sets. The low pass filter 116 may process the voltage measurements. The filtered voltage
measurements may be transformed to digital data by the analog to digital converter
114 and transmitted to the ECU 112 for storage (
e.g. in the memory 130) under the direction of software. This collection of voltage measurements
may be referred to herein as the "patch data." The software may store and have access
to each individual voltage measurement made at each surface electrode 122 during each
excitation of each pair of surface electrodes 122.
[0070] Generally, in an embodiment, three nominally orthogonal electric fields may be generated
by the series of driven and sensed electric dipoles in order to determine the location
of the elongate medical device 110 (
i.e., of one or more electrodes 128). Alternately, these orthogonal fields can be decomposed
and any pair of surface electrodes 122 (
e.g., non-orthogonal) may be driven as dipoles to provide effective electrode triangulation.
[0071] The patch data may be used, along with measurements made at one or more electrodes
128 and measurements made at other electrodes and devices, to determine a relative
location of the one or more electrodes 128. In some embodiments, electric potentials
across each of the six orthogonal patch electrodes 122 may be acquired for all samples
except when a particular surface electrode pair is driven. In an embodiment, sampling
electric potentials may occur at all patch electrodes 122, even those being driven.
[0072] As a part of determining locations of various electrodes 128, the ECU 112 may be
configured to perform one or more compensation and adjustment functions, such as motion
compensation. Motion compensation may include, for example, compensation for respiration-induced
patient body movement, as described in
U.S. patent application publication no. 2012/0172702.
[0073] Data sets from each of the patch electrodes 122 and the electrodes 128 are all used
to determine the location of the electrodes 128 within the patient 32. After the voltage
measurements are made for a particular set of driven patch electrodes 122, a different
pair of patch electrodes 122 may be excited by the signal generator 120 and the voltage
measurement process of the remaining patch electrodes 122 and electrodes 122 takes
place. The sequence may occur rapidly,
e.g., on the order of 100 times per second in an embodiment. The voltage on the electrodes
128 within the patient may bear a linear relationship with the position of the electrodes
128 between the patch electrodes 122 that establish the electrical fields, as more
fully described in
U.S. Pat. No. 7,263,397 referred to above.
[0074] In summary, Figure 11 shows an exemplary mapping and navigation system 16 that employs
seven body patch electrodes 122, which may be used for injecting current and sensing
resultant voltages. Current may be driven between two patches 122 at any time. Positioning
measurements may be performed between a non-driven patch 122 and, for example, belly
patch 122
B as a ground reference. An electrode bio-impedance may be computed according to the
following equation (2):

where
Vk is the voltage measured on electrode
k and
In→m is a known constant current driven between electrodes
n and m. The position of an electrode 128 may be determined by driving current between different
sets of patches 122 and measuring one or more impedances. In one embodiment, time
division multiplexing may be used to drive and measure all quantities of interest.
Position determining procedures are described in more detail in, for example,
U.S. Patent No. 7,263,397 and publication no.
2007/0060833 referred to above.
[0075] In addition to a simple impedance, the systems and methods described herein may be
used to determine a complex impedance respective of one or more electrodes on a catheter.
Such complex impedances may be used to assess a contact state between an electrode
and tissue. For example, as described in
U.S. Patent No. 8,403,925, a complex impedance may be used to determine an electrical coupling index (ECI),
which in turn may be used to assess contact between an electrode and tissue. Such
complex impedance, ECI, and related calculations and related contact state determinations
may be made by the tissue contact and coupling monitor shown in Figure 1.
[0076] Although numerous embodiments of this invention have been described above with a
certain degree of particularity, those skilled in the art could make numerous alterations
to the disclosed embodiments without departing from the spirit or scope of this disclosure.
All directional references (
e.g., plus, minus, upper, lower, upward, downward, left, right, leftward, rightward, top,
bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only
used for identification purposes to aid the reader's understanding of the present
disclosure, and do not create limitations, particularly as to the position, orientation,
or use of the any aspect of the disclosure. As used herein, the phrased "configured
to," "configured for," and similar phrases indicate that the subject device, apparatus,
or system is designed and/or constructed (
e.g., through appropriate hardware, software, and/or components) to fulfill one or more
specific object purposes, not that the subject device, apparatus, or system is merely
capable of performing the object purpose. Joinder references (
e.g., attached, coupled, connected, and the like) are to be construed broadly and may
include intermediate members between a connection of elements and relative movement
between elements. As such, joinder references do not necessarily infer that two elements
are directly connected and in fixed relation to each other. It is intended that all
matter contained in the above description or shown in the accompanying drawings shall
be interpreted as illustrative only and not limiting. Changes in detail or structure
may be made without departing from the scope of the invention as defined in the appended
claims.